Application for limited markets

An application for limited markets is intended for veterinary medicinal products for animal species other than those commonly kept as farm animals or pets. It is also intended for veterinary medicinal products for the treatment or prevention of diseases that occur infrequently or in limited geographical areas. The purpose of allowing applications for limited markets is to increase the availability of such veterinary medicinal products.

If a marketing authorisation is granted for a limited market, the Summary of Product Characteristics (SPC) will clearly state that only a limited assessment of safety or efficacy has been conducted due to the lack of comprehensive safety or efficacy data.

Submission of applications

If you want to apply for a marketing authorisation for a limited market, you must complete the European application form for this. For more information about submitting the dossier to the Veterinary Medicinal Products Unit, please refer to section on the submission of a dossier.

You may submit an application for a limited market via the centralised, decentralised (MRP/DCP) or national procedure. Always include the proof provided by the CVMP that Article 34 applies to the relevant veterinary medicinal product.

Required documents

If you want to apply for a marketing authorisation for a limited market, you must first request an opinion from the CVMP. The CVMP may classify the veterinary medicinal product as intended for a limited market.

In that case, you are not required to provide all the safety and efficacy data if you can demonstrate that:

• the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain safety and efficacy data have not been provided;
• the veterinary medicinal product is intended for a limited market.

However, the quality data must meet the requirements set out in Annex II to the Veterinary Medicinal Products Regulation.

More information on applications for limited markets can be found on the EMA website as well as here on the HMA website.

Extension of marketing authorisations for limited markets

A marketing authorisation for a limited market is valid for a period of five years. To qualify for an extension, you must submit an application at least six months before the expiry of the validity period. This marketing authorisation for a limited market will then remain valid until a decision is taken regarding the application. If the benefit of the availability on the market of the veterinary medicinal product to the animal or public health outweighs the risk inherent in the fact that certain safety and efficacy data have not been provided, the validity of the marketing authorisation for a limited market will be extended by a period of five years. If you submit all the missing safety and efficacy data, your marketing authorisation for a limited market may be replaced by a marketing authorisation for an unlimited period.
 

The legal basis for applications for limited markets is set out in Articles 23 and 24 of the Veterinary Medicinal Products Regulation.